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A Phase I Study of OSI-906 in Combination With Pemetrexed in Advanced Solid Tumor Malignancies

NCT01567384 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-11-20

No results posted yet for this study

Summary

The purpose of the study is to test the safety of an experimental drug called OSI-906 when combined with pemetrexed at different dose levels and to find out the optimal doses of the two drugs that can be given as a combination. Pemetrexed has been widely used for treatment of certain solid organ tumors and is effective and approved for use in treatment of lung cancer and mesothelioma.

Conditions

Interventions

DRUG

OSI-906 and Pemetrexed

Pemetrexed will be administered intravenously on day 1 of cycle 1 at a dose of 500 mg/m2 as a 10-minute infusion. Subsequent doses will be defined by tolerability. OSI-906 will be administered orally twice daily (12 hours apart) at approximately the same times each day on a continuous schedule, beginning on Day 0 of cycle 1.

Sponsors & Collaborators

  • OSI Pharmaceuticals

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Suresh Ramalingam, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01567384 on ClinicalTrials.gov